Omoleye Oguntoyinbo
⚠️ Moderate Risk
FEI: 3008699759 • Lagos, Lagos • NIGERIA
FEI Number
3008699759
Location
Lagos, Lagos
Country
NIGERIAAddress
67 Owodunni St Palmgrove, , Lagos, Lagos, Nigeria
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/18/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/18/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/18/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/18/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/18/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 1/18/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Omoleye Oguntoyinbo's FDA import refusal history?
Omoleye Oguntoyinbo (FEI: 3008699759) has 6 FDA import refusal record(s) in our database, spanning from 1/18/2013 to 1/18/2013.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Omoleye Oguntoyinbo's FEI number is 3008699759.
What types of violations has Omoleye Oguntoyinbo received?
Omoleye Oguntoyinbo has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Omoleye Oguntoyinbo come from?
All FDA import refusal data for Omoleye Oguntoyinbo is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.